Trials / Completed
CompletedNCT01544348
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 295 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Phase 1 study to evaluate the safety of MEDI4212.
Detailed description
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (\>=) 30 international units per milliliters (IU/mL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1. |
| BIOLOGICAL | Omalizumab | A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1. |
| BIOLOGICAL | MEDI4212 5 mg Subcutaneous | A single dose of MEDI4212 5 mg injection subcutaneously on Day 1. |
| BIOLOGICAL | MEDI4212 15 mg Subcutaneous | A single dose of MEDI4212 15 mg injection subcutaneously on Day 1. |
| BIOLOGICAL | MEDI4212 60 mg Subcutaneous | A single dose of MEDI4212 60 mg injection subcutaneously on Day 1. |
| BIOLOGICAL | MEDI4212 150 mg Subcutaneous | A single dose of MEDI4212 150 mg injection subcutaneously on Day 1. |
| BIOLOGICAL | MEDI4212 300 mg Subcutaneous | A single dose of MEDI4212 300 mg injection subcutaneously on Day 1. |
| BIOLOGICAL | MEDI4212 300 mg Intravenous | A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-03-05
- Last updated
- 2014-12-30
- Results posted
- 2014-12-30
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01544348. Inclusion in this directory is not an endorsement.